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Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molly A. Wanner, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01149876
First received: April 30, 2010
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.


Condition Intervention Phase
Hyperpigmentation
 Other: Nu Skin Product
Other: Cosmetic instrument
Drug: Tretinoin cream 0.05
Other: CeraVe moisturizer
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation

Resource links provided by NLM:

MedlinePlus related topics: Cosmetics Rashes
Drug Information available for: Tretinoin
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • change in hyperpigmentation of the face [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: No ]
    primary outcome measure will be change in hyperpigmentation of baseline compared to week 16


Secondary Outcome Measures:
  • change in rhytides and roughness [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    secondary outcome measures will be change in rhytides and roughness of baseline compared to week 16


Enrollment: 80
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nu Skin Product Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.
Experimental: Nu Skin product with galvanic spa system Other: Nu Skin Product
Thin layer of Nu Skin product applied to face.
Other: Cosmetic instrument
Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
Active Comparator: Tretinoin cream 0.05 Drug: Tretinoin cream 0.05
Thin layer of tretinoin applied to face.
Placebo Comparator: over the counter moisturizer Other: CeraVe moisturizer
Thin layer of CeraVe applied to face.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to understand and sign informed consent.
  • Able to complete study and comply with study procedures.
  • Caucasian female ages 25-55.
  • Presence of photodamage and lentigines of II-III on the Glogau Photoaging
  • Must be willing to avoid laser and light treatments, treatments with filler, chemical peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.
  • Must be willing to avoid changing topical moisturizers and cosmetics during the study.
  • Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study.

Exclusion Criteria:

  • Cosmetic treatment of face, such as laser or light treatment, filler, Botox, microdermabrasion, or chemical peels 6 months prior to study or during study.
  • Current smoker.
  • Pregnant, nursing, or planning to become pregnant during study.
  • Currently taking drugs including oral retinoids or any other medication with a known clinically significant drug interaction with topical tretinoin.
  • Known hypersensitivity to retinoids. History of severe retinoid dermatitis.
  • History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
  • Concurrent participation in another clinical study or participation 30 days prior to enrollment that includes exposure to an investigational drug that would interfere with this study.
  • Any disease or condition which would interfere with study participation or unduly increase risk.
  • Presence of an electrically sensitive support system such as a pacemaker.
  • Known history of epilepsy.
  • Presence of metal implants or metal braces on teeth.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149876

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Molly Wanner, MD MGH
  More Information

No publications provided

Responsible Party: Molly A. Wanner, MD, Assistant Physician, Dermatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01149876     History of Changes
Other Study ID Numbers: 2009-P-002803
Study First Received: April 30, 2010
Last Updated: May 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Tretinoin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013